The Partnership for Safe Medicines Letter to Congress – February 28, 2017

February 27, 2017

The Partnership for Safe Medicines (PSM) today sent a letter to all members of Congress urging them to continue protecting Americans and stand against efforts that would allow substandard and even dangerous counterfeit medicines to flow freely across U.S. borders and into the hands of the American people. The letter, signed by nearly 170 groups, is reprinted in full below. [UPDATE: List of signatories updated as of March 7, 2017. See below.]

February 28, 2017

Dear Congress,

As a coalition whose outreach and operations involve educating health care workers and patients in all fifty states, and whose membership is comprised of more than 60 organizations committed to the safety of prescription drugs and protecting U.S. consumers against counterfeit, substandard or otherwise unsafe medicines, the Partnership for Safe Medicines, its members and other interested stakeholders are deeply concerned that importation proposals will undermine America’s existing and proposed drug safety protocols.

Whether offered broadly or for a narrow set of medications, there’s never a good time to sacrifice safety. No patient is served well by a drug from an unknown source, that has been stored under unknown conditions, and which contains unknown ingredients because it passed through unlicensed, foreign middlemen who operate beyond U.S. law.

Drug importation advocates believe that drugs purchased from countries such as Canada and the United Kingdom are safe because of their strict health regulations. Unfortunately, this is simply not true. For example, many customers of “Canadian pharmacies” report getting their shipments straight from Pakistan, India, and Turkey. Additionally, a large share of medicines that flow through Canada are counterfeit, and while it may seem safe to import medicines from developed countries like Canada and Western Europe, those medicines may have originated from countries all over the world.

Canadian law does not prohibit the transshipment of drugs from any country – including from countries with low manufacturing standards – into Canada and then on to the U.S. In fact, Canadian law explicitly states that the Canadian equivalent to the FDA does not have to inspect drugs for export.

Moreover, Canadian pharmacists aren’t allowed to dispense to Americans without a Canadian physician’s prescription.
Proposals allowing importation would undermine nearly two decades of drug safety policy. Large volume importation of prescription drugs could be permitted under current law only if the Health and Human Services (HHS) Secretary was willing to certify that imported drugs “pose no additional risk to the public’s health and safety, and result in a significant reduction in the cost of covered products to the American consumer.” Recent HHS Secretaries have not been willing to certify such large scale importation as of no significant risk to the public health or that any potential cost savings would outweigh the resources that would be required to ensure the safety and efficacy of any imported products. We urge you to focus on protecting the nation’s drug supply to maintain access to safe medicines for US patients.